Senior Clinical Operations Manager for Rare Disease Trials
7 days ago
Company Overview: Amylyx Pharmaceuticals is a pharmaceutical company based in Cambridge, Massachusetts, dedicated to the discovery and development of potential treatments for diseases including Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS).
About the Role: We are seeking an experienced Senior Clinical Operations Manager to lead clinical studies in Post-Bariatric Hypoglycemia (PBH), ALS, PSP, Wolfram Syndrome and/or other diseases under study at Amylyx.
Key Responsibilities:
- Clinical Study Management: Directly responsible for the conduct of trials from start-up through close-out, ensuring effective planning and execution, risk management, data integrity, quality and compliance with Company SOPs, ICH-GCP guidelines, GDPR, and other regulations and patient safety standards.
- Operational Excellence: Ensures appropriate operational procedures are implemented or adhered to, to assure high-quality trial data and operational excellence of assigned studies.
- Metric Development: Develops, analyzes, and reports on metrics for clinical programs.
- Collaboration and Communication: Communicates trial status, issues, mitigations, and lessons learned to relevant cross-functional stakeholders, including senior leadership.
Required Qualifications:
- Experience: Minimum 8 years of clinical operations experience in a pharmaceutical/biotech, and/or CRO setting; global clinical trial operations experience, study startup through close-out.
- Skills and Qualities: Effective project management skills, strong vendor management skills, inspection-ready mindset, ability to manage competing priorities, detail-oriented, and comfortable multi-tasking. Exceptional knowledge of GCP, ICH, and FDA regulations.
Salary and Benefits: The estimated salary range for this position is $120,000 - $180,000 per year, depending on experience. Additionally, we offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
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